Apparatus for attachment of heart valve holder to heart valve prosthesis

ABSTRACT

A holder for engaging a heart valve prosthesis during implantation includes a mechanism for attaching the holder to the heart valve prosthesis. The heart valve prosthesis includes a circular valve body having an annulus with a substantially annular aperture therein. At least one movable occluder is carried in the aperture and is movable between an open position and a closed position. The attachment mechanism attaches to the occluder thereby securing the holder to the heart valve prosthesis.

The present invention relates to devices for implanting heartprostheses. More specifically, the invention relates to attachment of aheart valve holder to a heart valve prosthesis.

BACKGROUND OF THE INVENTION

Holders for holding heart valve prostheses during implantation areknown. They are used for positioning, holding, supporting and presentingthe valve during surgery. U.S. Pat. No. 3,828,787, issued Aug. 13, 1974,to Anderson et al., entitled COLLET FOR HOLDING HEART VALVE, shows aheart valve holder carried on a distal end of an elongated handle. U.S.Pat. No. 4,932,965, issued Jun. 12, 1990, to Phillips, entitledARTIFICIAL VALVE, AND NEEDLE AND SUTURE HOLDER AND METHOD OF USING SAME,shows another heart valve holder in which the valve is held againstdistal ends of a pair of elongated legs during implantation.

Typically, heart valve replacement surgery is an involved procedure inwhich a sternotomy or thoracotomy is performed and the chest cavity ofthe patient must be widely opened to provide access to the patient'sheart. This provides a surgeon with direct, unobstructed access to theheart. However, this procedure requires a prolonged period to recoverfrom the trauma suffered to the upper torso.

Recently, a procedure has been developed wherein open heart surgery isperformed through trocars placed in small incisions between ribs of thepatient. This is described in International Publication No. WO 95/15715,entitled DEVICES AND METHODS FOR INTRACARDIAC PROCEDURES; U.S. Pat. No.5,433,700, issued Jul. 18, 1995, to Peters, entitled METHOD FORINTRALUMINALLY INDUCING CARDIOPLEGIC ARREST AND CATHETER FOR USETHEREIN; U.S. Pat. No. 5,425,705, issued Jun. 20, 1995, to Evard et al.,entitled THORACOSCOPIC DEVICES AND METHODS FOR ARRESTING THE HEART; andInternational Publication No. WO 94/18881, entitled METHOD FORPERFORMING THORASCOPIC CARDIAC BYPASS PROCEDURES. In this procedure,elongated tools are used to operate on the heart through the trocars. Asdiscussed in Publication No. WO 95/15715, this procedure can be usedduring heart valve replacement. When a heart valve prosthesis isinserted through a trocar, extreme care has to be taken for protectingthe occluders in the valve, and once inserted, it becomes desirable tochange the orientation of the valve prior to implantation to simplifythe suturing of the heart valve prosthesis in place.

The trocar results in minimal rib spreading and does not involve thesignificant chest trauma associated with traditional open heart surgery.One advantage of this procedure is that the recovery period can bereduced significantly. Unfortunately, mechanical heart valves and theassociated assembly used for implantation are large relative to theintercostal space between the ribs and are difficult to fittherethrough. Further, the heart valve holder must be securely attachedto the heart valve prosthesis and yet be easily removed once the valvehas been attached to the heart tissue annulus.

SUMMARY OF THE INVENTION

A device for engaging a heart valve prosthesis during implantationincludes a mechanism for attaching the device to the heart valveprosthesis. The heart valve prosthesis includes a circular valve bodyhaving an annulus with a substantially annular aperture therein. Atleast one movable occluder is carried in the annulus and is movablebetween an open position and a closed position. The attachment mechanismincludes a member which engages to the occluder(s), thereby affixing thedevice to the valve prosthesis at the occluder(s). The member isselectively removable from the occluder(s) thereby releasing the devicefrom the occluder(s). In one embodiment, an elongated handle couples tothe device and extends away from the device in a plane generallyparallel with a plane formed by the annulus of the heart valveprosthesis.

In one embodiment, the attachment mechanism is disengaged by withdrawingthe attachment mechanism from the occluder. This may be by directlypulling on the attachment mechanism or by actuating a withdrawalapparatus.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a cross sectional view of a heart valve prosthesis adjacent aholder in accordance with one embodiment.

FIG. 1B is a cross sectional view of the holder and heart valveprosthesis of FIG. 1A showing a holder engaged with the heart valveprosthesis.

FIG. 1C is a top plan view of the holder of FIG. 1B in the engagedposition.

FIG. 2 is a cross sectional view of a heart valve holder in accordancewith another embodiment engaged with a heart valve prosthesis.

FIG. 3 is a cross sectional view of a heart valve holder in accordancewith another embodiment engaged with a heart valve prosthesis.

FIG. 4A is a cross sectional view showing a holder in accordance withanother embodiment adjacent a heart valve prosthesis.

FIG. 4B is a cross sectional view of a holder of FIG. 4A engaged withthe heart valve prosthesis.

FIG. 5A is a cross sectional view of a holder in accordance with anotherembodiment adjacent a heart valve prosthesis.

FIG. 5B is a cross sectional view of the holder of FIG. 5A engaged withthe heart valve prosthesis.

FIG. 6A is a cross sectional view of a holder in accordance with anotherembodiment engaged with the heart valve prosthesis.

FIG. 6B is a cross sectional view of the holder and heart valveprosthesis of FIG. 6A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention relates to attachment of a prosthetic heart valve holderto a heart valve prosthesis. The holder is used to position the heartvalve prosthesis during implantation. In one embodiment, thisimplantation is through minimally invasive surgery such as whenperformed through a small trocar. The holder and valve are carried atthe distal end of a handle which extends perpendicular to the axis ofthe valve annulus during insertion through the trocar. Reference is madeto copending application Ser. No. 08/526,530 filed on even date herewithentitled LOW PROFILE MANIPULATORS FOR HEART VALVE PROSTHESES. Forpurposes of this description of the invention, the holder and attachmentmechanism will be described generally with regard to its use. The holderand attachment mechanism may be used with any appropriate heart valveprosthesis including heart valve prostheses which are available from St.Jude Medical, Inc., of St. Paul, Minn.; Baxter Healthcare Corp., EdwardsCVS Div., Irvine, Calif.; Medtronic, Inc., Minneapolis, Minn.; Shiley,Inc., Irving, Calif.; Omniscience Medical Inc., Grove Heights, Minn.;Carbomedics, Inc., Austin, Tex.; and Sorin Biomedica, Saluggia, Italy.In general, heart valve prostheses depicted herein are shown in ageneric form and the scope of the present invention is intended to covervariations required to adapt the holder and attachment mechanism todifferent heart valve prostheses.

FIG. 1A is a cross sectional view of heart valve prosthesis 10 and heartvalve holder 11 in accordance with one embodiment of the presentinvention. Prosthesis 10 includes suture cuff 12 and heart valveprosthesis body 14. Body 14 forms an annulus for allowing blood flowtherethrough. Occluders 16 are positioned in the heart valve prosthesisbody 14 and are movable between an open position as shown in FIG. 1A toa closed position as shown in FIG. 1B. Occluder(s) 16 rotate aboutpivots 18. Although the particular heart valve prosthesis 10 has beenshown in accordance with one embodiment, other heart valves may also beused with the present invention. For example, the heart valve prosthesismay include different numbers of occluders including a single occluder,may have a different orifice or annulus shape, or the occluders mayoperate in accordance with a different mechanism.

Heart valve prosthesis holder 11 includes a top member 20 having lipportion 22 which engages the top rim of heart valve prosthesis body 14.Holder 11 includes interior extensions 24 which provides a surfaceadapted to engage the interior surface of heart valve prosthesis body14. Distal ends 26 protrude beyond the bottom rim of heart valveprosthesis body 14 and occluder(s) 16. Holder 11 includes capture rod 28which is positioned between occluder(s) 16, and in the embodiment ofFIGS. 1A-1C, is aligned between pivots 18. In FIG. 1A, a capture block30 of holder 11 is shown in an open or released position. Capture block30 includes occluder engaging surfaces 32 adapted to conform to thesurfaces of occluders 16 and maintain occluders 16 in the partiallyclosed position shown in FIG. 1B. FIG. 1B shows capture block 30 movedin a closed position downward relative to top member 20 such thatoccluder engaging surfaces 32 engage occluders 16 in the partiallyclosed position. This causes the occluder(s) 16 to be captured betweencapture rod 28 and occluder engaging surfaces 32 of capture block 30.Capture block 30 includes suture flanges 36.

FIG. 1C is a top plan view of holder 11 showing sutures 38 which securecapture block 30 to top member 20 by extending around suture lips 36through suture holes 40.

In operation, heart valve prosthesis 10 is held by heart valve holder 11as shown in FIGS. 1B and 1C at occluders 16. Occluders 16 are maintainedin a partially or fully closed position and are protected from damage bydistal portions 26 or heart valve prosthesis body 14 duringimplantation. In this position, a surgeon attaches heart valveprosthesis 10 to the tissue annulus formed by excision of the naturalheart valve from a patient. Suture cuff 12 is sutured to the hearttissue annulus by techniques known in the art. Following attachment ofheart valve 10 to the tissue annulus, heart valve holder 11 may beremoved by cutting sutures 38 and moving capture block 30 to the openposition shown in FIG. 1A. Removal and manipulation of holder 11 may bewith an elongated handle (not shown). This frees occluder(s) 16 suchthat holder 11 may be removed from prosthesis 10.

FIG. 2 is a cross sectional view of heart valve holder 50 in accordancewith another embodiment engaged with heart valve prosthesis 10. Heartvalve holder 50 includes top member 52 having lip portion 54 adapted forengagement with the top rim of heart valve prosthesis body 14. Holder 50includes interior extensions 56 which conform to the interior surface ofheart valve prosthesis body 14 and distal extensions 58 which extendbeyond the lower rim of heart valve prosthesis body 14 and occluder(s)16. Top member 52 includes occluder conforming surfaces 60 which areadapted to conform to occluders 16 when holder 50 is engaged with heartvalve prosthesis 10 as shown in FIG. 2. Top member 52 includes sutureholes 62 adapted for receiving a suture 64. Suture 64 extends around topmember 52, through suture holes 62 and around occluders 16, therebysecuring holder 50 to heart valve prosthesis 10. Suture 64 is securedwith knot 66. Holder 50 is held against prosthesis 10 at occluderconforming surfaces 60 and lip portion 54 due to the pressure applied onoccluders 16 by suture 64. Distal extensions 58 protect occluders 16from damage during implantation. Following implantation of heart valveprosthesis 10, holder 50 may be removed by cutting suture 64 anddisengaging holder 50 from heart valve prosthesis 10. Although only asingle suture 64 is shown, multiple sutures may also be used.

FIG. 3 is a cross sectional view of heart valve prosthesis holder 80 inaccordance with another embodiment engaged with heart valve prosthesis.Holder 80 includes top member 82 and lip portion 84. An interiorextension 86 generally conforms to the interior surface of heart valveprosthesis body 14. Distal extensions 88 extend beyond the bottom ofheart valve prosthesis body 14. Top member 82 includes occluderconforming surfaces 90 adapted to conform to occluders 16, as shown inFIG. 3. Top member 82 includes opening 94 adapted to receive locking key96. Locking key 96 includes interior locking portion or member 98 havingoccluder engaging surfaces 100 and handle 102.

Holder 80 is held to prosthesis 10 between conforming surfaces 90 of topmember 82 and engaging surfaces 100 of locking key 96. Followinginsertion and attachment of heart valve prosthesis 10 to the hearttissue annulus of a patient, holder 80 is removed by rotating lockingkey 96 ninety degrees about the axis of prosthesis 10 such thatoccluders 16 are freed from occluder engaging surfaces 100. In thisposition, occluder(s) 16 are disengaged. Thus, prosthesis holder 80 maybe removed from valve prosthesis 10. Alternatively, member 98 may beremoved from valve holder 80 through opening 94 in top member 82. Holder80 may then be removed from prosthesis 10. Distal extensions 88 protectoccluders 16 during implantation. Variations on this embodiment includechanging the position or length of the engaging surface 100 andconforming surface 90. Another variation would be insertion of a keymember(s) adjacent to, but not between, occluder(s) 16, which engagedistal ends of occluder(s) 16 such that interior extension 86 would notbe required.

Alternatively, holder 80 may be held to prosthesis 10 between lipportion 84 and engaging surface 100 of locking key 96.

FIG. 4A is a cross sectional view of a heart valve prosthesis holder 110in accordance with another embodiment. Holder 110 includes top member112 having lip portion 114 adapted for engaging heart valve prosthesisbody 14. Interior extensions 116 conform to the interior surface ofheart valve prosthesis body 14 and connect to distal extensions 118which extend beyond the bottom rim of heart valve prosthesis body 14.Top member 112 includes occluder conforming surfaces 120 adapted forengaging occluders 16. Opening 122 in top member 112 receives inflatableelement 124. Inflatable element 124 is shown in a deflated condition inFIG. 4A and in an inflated condition in FIG. 4B. In an inflatedcondition, inflatable element 124 provides occluder engaging surfaces126 such that occluders 16 are captured between engaging surfaces 126and conforming 120, thereby securing holder 110 to heart valveprosthesis 10. Support is also provided by lip portion 114. Distalextensions 118 protect occluders 16 during implantation. Followingattachment of heart valve prosthesis 10 to the heart tissue annulus,holder 110 is removed by deflating inflatable element 124 such thatholder 110 may be lifted from prosthesis 10. An elongated controlcoupling may be provided to element 124 to selectively, remotely deflateelement 124.

Alternatively, valve prosthesis 10 is captured between engaging surface126 and lip portion 114 of holder body 110.

FIG. 5A is a cross sectional view of a holder 140 in accordance withanother embodiment adjacent heart valve prosthesis 10. Prosthesis 10 isshown in simplified form having body 14, occluders 16 and pivots 18.Holder 140 includes gripper 142 having attachment mechanisms 144A and144B which extend around edges of occluders 16. A plunger 146 extendsthrough an opening in gripper 142 and is shown in a withdrawn positionin FIG. 5A.

In FIG. 5B, tip portion 148 of plunger 146 causes attachment mechanisms144A to spread apart thereby locking gripper 142 to occluders 16. In theembodiment of holder 140 in FIGS. 5A and 5B, a control couplingmechanism (not shown) may be provided to control operation of plunger146 from a remote location. Similarly, such a control mechanism may beused in the other embodiments set forth herein.

FIG. 6A is a cross sectional view of holder 150 in accordance withanother embodiment engaged with heart valve prosthesis 10. Holder 150 inFIG. 6A is similar to holder 140 of FIGS. 5A and 5B. Holder 150 includesbody 152 having engagement mechanisms 154 which engaged edges ofoccluders 16.

FIG. 6B is a cross sectional view of holder 150 in heart valveprosthesis 10. FIG. 6B is a cross sectional view with valve 10 in holder150 rotated ninety degrees about the axis of valve 10 in FIG. 6A. FIG.6B shows holder 150 offset from the center axis of valve 10 such thatholder 150 is disengaged from valve 10. Holder 150 may be positioned toengage occluders 16 by moving holder 150 in the direction indicated byarrow 156 in FIG. 6B. Holder 150 includes suture hole 158 shown in FIG.6A which is capable of receiving a suture (not shown) to secure holder150 in an engaged position with occluders 16.

As used herein, attachment mechanism is used to mean a mechanism forattaching to the occluder. The preferred embodiments set forth a numberof attachment mechanisms. However, the term "attachment mechanism" isintended to describe any other mechanism for attaching a valve to anoccluder which is within the scope of the invention.

It should be understood that the present invention extends to anyvariation or embodiment which would be apparent to those skilled in theart. The concepts set forth herein are applicable to any appropriatevalve configuration for both aortic and mitral implantation.

Typically, the holders described herein are attached to an elongatedhandle such that a surgeon may manipulate the heart valve using theproximal end of the handle during implantation.

Although the present invention has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

What is claimed is:
 1. An apparatus for holding a heart valve prosthesisand providing a low profile during implantation, the heart valveprosthesis including a heart valve prosthesis body and a movableoccluder having a first occluder surface and a second occluder surfaceopposite the first occluder surface, the apparatus comprising:a topmember sized to fit proximate an annulus of the heart valve prosthesis;a lip portion coupled to the top member adapted for abutting the annulusof the heart valve prosthesis; an interior extension coupled to the topmember extending through heart valve prosthesis body and generallyconforming to an interior portion of the prosthesis body; a distalextension coupled to the interior extension extending beyond the heartvalve prosthesis body opposite the top member to protect the movableoccluder; a conforming surface in the top member shaped to conform tothe first occluder surface to maintain the first occluder surface in asubstantially closed position when the top member and lip portion engagethe prosthesis body; and a suture extending around the top member andadapted to extend around the movable occluder, thereby coupling the topmember to the heart valve prosthesis body and the conforming surface tothe fist occluder surface and maintaining the movable occluder in thesubstantially closed position whereby the occluder is protected fromdamage by the heart valve prosthesis body and the distal extension. 2.The apparatus of claim 1 including a second conforming surface adaptedto conform to a first surface of a second movable occluder of the heartvalve prosthesis to maintain the second movable occluder in asubstantially closed position.
 3. The apparatus of claim 1 wherein thetop member includes a suture hole formed therein for receiving thesuture.